Bass, Berry & Sims attorney Stewart Kameen shared insight in several articles examining the call for an investigation into the Food and Drug Administration’s (FDA) controversial approval of an Alzheimer’s disease treatment – the drug Aduhelm – from Biogen. The FDA’s approval process has sparked calls for an investigation by the Department of Health and Human Services’ Office of Inspector General (OIG). On July 9, the FDA’s Acting Commissioner Janet Woodcock requested an independent review and assessment to investigate the interaction between the agency and Biogen prior to the drug’s approval.
As a growing chorus of advocates and academics call for an investigation into the relationship between Biogen executives and Billy Dunn, head of the FDA neuroscience division, Stewart notes that external pressure alone can’t force the OIG into action.
Stewart, who previously served as Senior Counsel in the Office of Counsel to the Inspector General – Industry Guidance Branch, told STAT News “There’s certainly a lot of momentum for an investigation, or an audit, or a review,” but he went on to highlight and praise the agency’s independence.
The full articles and links are listed below:
- “Woodcock Requests Independent Review Of Biogen-FDA Aduhelm Interaction … Not Approval Decision,” Pink Sheet (July 9, 2021)
- “Calls Grow for an Investigation into FDA Approval of Biogen’s Alzheimer’s Drug,” STAT News (June 30, 2021).